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Dry Printer DP-X1

by Smart Health Biotech (Guangxi) Co., Ltd. China EUDAMED

Ref 58195 70048Model DP-X1

EMDN Z11079005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69263491FPFJ Basic UDI-DIDate13 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Medical Dry Printer
Model / Reference
DP-X1, 58195 70048
Primary DI / UDI-DI
06958195700486
Basic UDI-DI
69263491FPFJ
EMDN Code
Z11079005 Printing machines
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000040855
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Smart Health Biotech (Guangxi) Co., Ltd.

See all devices from Smart Health Biotech (Guangxi) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4b634a28-da5f-4900-ad3f-4f7740201f3c 61 fields · synced 22 Oct 2026